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目的:评价脾虚久泻方治疗小儿慢性迁延性非感染性腹泻脾肾阳虚证的疗效，探讨该方对患儿免疫功能的影响。方法:随机对照试验研究 。选取2021年12月－2023年2月河南中医药大学第一附属医院儿科门诊76例腹泻患儿作为观察对象，并按随机数字表法分为２组，每组38例。观察组服用脾虚久泻方治疗，对照组口服蒙脱石散与双歧杆菌四联活菌片治疗。2组均治疗30 d。分别于治疗前后进行主症、中医证候、中医体征评分，采用免疫比浊法检测免疫球蛋白IgM、IgA、IgG水平，评价临床疗效。 结果:观察组总有效率为94.74%（36/38）、对照组为78.95%（30/38），2组比较差异有统计学意义（ χ2=14.05， P=0.003）。主症积分：观察组治疗后大便次数［（1.86±0.25）分比（2.03±0.49）分， t=7.14］、大便性状［（1.62±0.26）分比（1.98±0.37）分， t=8.26］积分低于对照组（ P<0.001）。中医证候积分：观察组治疗后腹痛［（0.68±0.13）分比（0.74±0.37）分， t=7.38］、脘腹胀满［（0.43±0.25）分比（0.75±0.23）分， t=2.16］、食欲［（0.50±0.10）分比（0.88±0.15）分， t=4.35］、恶心呕吐［（0.18±0.33）分比（0.34±0.36）分， t=6.53］、神疲乏力［（0.34±0.24）分比（0.43±0.25）分， t=5.62］、脱水［（0.30±0.11）分比（0.68±0.13）分， t=5.87］积分及总分［（5.63±4.33）分比（9.63±5.53）分， t=16.07］低于对照组（ P<0.01或 P<0.05）。中医体征积分：观察组治疗后面色虚浮［（0.18±0.33）分比（0.24±0.13）分， t=2.63］、形寒肢冷［（0.20±0.11）分比（0.28±0.14）分， t=4.13］、脱肛［（0.08±0.33）分比（0.14±0.37）分， t=3.64］、小便清长［（0.23±0.11）分比（0.28±0.13）分， t=8.27］积分低于对照组（ P<0.01或 P<0.05）。观察组治疗后免疫球蛋白IgA［（0.52±0.21）g/L比（0.40±0.26）g/L， t=8.15］、IgM［（8.76±1.16）g/L比（7.68±1.43）g/L， t=10.67］、IgG［（0.89±0.39）g/L比（0.62±0.33）g/L， t=12.15］水平高于对照组（ P<0.001）。 结论:脾虚久泻方可有效改善慢性迁延性非感染性腹泻脾肾阳虚证患儿的临床症状及体征，增强患儿免疫力，提高临床疗效。

Objective:To evaluate the clinical efficacy of Pixu Jiuxie Prescription in the treatment of chronic and prolonged non-infectious diarrhea (spleen kidney yang deficiency type) in children; To discuss its effects on immune function of patients.Methods:Randomized controlled trial study was conducted. 76 children with chronic and prolonged non-infectious diarrhea of spleen and kidney yang deficiency type who were treated at the Pediatric Clinic of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from December 2021 to February 2023 were selected as the research subjects. They were divided into two groups, with 38 cases in each group. The observation group was orally treated with Pixu Jiuxie Prescription, and the control group was orally treated with Diosmectite and Bifidobacterium Quadruple Viable Tablets. The treatment for both groups lasted for 30 d. Main symptoms, TCM syndromes, and TCM symptoms were scored before and after the treatment. Immunoassay was used to detect the levels of immunoglobulin IgM, IgA, and IgG, and clinical efficacy was evaluated.Results:After treatment, the total effective rate of the observation group was 94.74% (36/38), which was significantly higher than that of the control group 78.95% (30/38), with statistical significance ( χ2=14.05, P=0.003); Main symptoms: the number of stools in the observation group (1.86 ± 0.25 vs. 2.03 ± 0.49, t=7.14), and stool characteristics (1.62 ± 0.26 vs. 1.98 ± 0.37, t=8.26) were lower than those in the control group ( P<0.001). TCM syndrome: after treatment, the abdominal pain (0.68 ± 0.13 vs. 0.74 ± 0.37, t=7.38), abdominal distension (0.43 ± 0.25 vs. 0.75 ± 0.23, t=2.16), appetite (0.50 ± 0.10 vs. 0.88 ± 0.15, t=4.35), nausea and vomiting (0.18 ± 0.33 vs. 0.34 ± 0.36, t=6.53), fatigue and weakness (0.34 ± 0.24 vs. 0.43 ± 0.25, t=5.62), and dehydration (0.30 ± 0.11 vs. 0.68 ± 0.13, t=5.87) integration and the total score of (5.63 ± 4.33 vs. 9.63 ± 5.53, t=16.07) observation group were lower than those in the control group ( P<0.01 or P<0.05). TCM symptoms: after treatment, the scores of color deficiency (0.18 ± 0.33 vs. 0.24 ± 0.13, t=2.63), cold limbs (0.20 ± 0.11 vs. 0.28 ± 0.14, t=4.13), prolapse (0.08 ± 0.33 vs. 0.14 ± 0.37, t=3.64), and clear urine (0.23 ± 0.11 vs. 0.28 ± 0.13, t=8.27) in the observation group were lower than those in the control group ( P<0.01 or P<0.05). After treatment, the levels of immunoglobulin IgA [(0.52 ± 0.21) g/L vs. (0.40 ± 0.26) g/L, t=8.15], IgM [(8.76 ± 1.16) g/L vs. (7.68 ± 1.43) g/L, t=10.67], and IgG [(0.89 ± 0.39) g/L vs. (0.62 ± 0.33) g/L, t=12.15] in the observation group were higher than those in the control group ( P<0.01). Conclusion:Pixu Jiuxie Prescription can effectively improve the clinical symptoms and signs of children with chronic and prolonged non-infectious diarrhea with spleen kidney yang deficiency syndrome, enhance their immunity, and improve clinical efficacy.